CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25- titanium dioxide, zinc oxide liquid

CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25 by

Drug Labeling and Warnings

CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium Dioxide 2.4%

Zinc Oxide 5.9%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

dimethiconewater\aqua\eaupeg-10 dimethiconebutylene glycolvinyl dimethicone/methicone silsesquioxane crosspolymerphenyl trimethicone isododecanebutyloctyl salicylateisodecyl isononanoatelauryl peg-9 polydimethylsiloxyethyl dimethiconealcohol denat.dimethicone/vinyl dimethicone crosspolymerhydrated silicaascorbyl glucosidetetrahexyldecyl ascorbatemagnesium ascorbyl phosphatesodium hyaluronatetocopheryl acetatelaminaria saccharina extractpolygala senega root extractberberis vulgaris extractnymphaea alba root extractcamellia sinensis leaf extractsalvia hispanica seed extractmolasses extract\saccharum officinarum\extrait de mélassedimethoxytolyl propylresorcinolcaffeineniacinamidesalicylic acid linoleic acidtocopherollactoperoxidaseglucose oxidaselactobacillus fermentglycyrrhetinic acid cholesteroljojoba estersglucosepolysilicone-11 laureth-7trimethylsiloxysilicatesorbitan sesquioleatelecithinxanthan gumsilicacaprylyl glycoldimethicone/peg-10/15 crosspolymer disteardimonium hectoritetriethoxycaprylylsilane aluminapropylene carbonatedipropylene glycol sodium chloridesodium hydroxidecitric acid potassium phosphatetetrasodium edtasodium citratepotassium sorbatephenoxyethanol[+/-micatitanium dioxide (ci 77891)iron oxides (ci 77491)iron oxides (ci 77492)iron oxides (ci 77499)] [iln47715]

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

CLINIQUE

even better

clinical

serum foundation

broad spectrum

SPF 25

PERFECTS + TRANSFORMS

1 FL.OZ.LIQ./30 ml ℮

INGREDIENTS AND APPEARANCE

CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25 
titanium dioxide, zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	59 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
NYMPHAEA ALBA ROOT (UNII: 866B05KWBR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHIA SEED (UNII: NU0OLX06F8)
MOLASSES (UNII: LSU3YX0KZO)
DIMETHOXYTOLYL PROPYLRESORCINOL (UNII: 4OD5GIH1UK)
CAFFEINE (UNII: 3G6A5W338E)
NIACINAMIDE (UNII: 25X51I8RD4)
SALICYLIC ACID (UNII: O414PZ4LPZ)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TOCOPHEROL (UNII: R0ZB2556P8)
MYELOPEROXIDASE (UNII: JQZ6YM58U5)
GLUCOSE OXIDASE (UNII: 0T8392U5N1)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
ENOXOLONE (UNII: P540XA09DR)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
LAURETH-7 (UNII: Z95S6G8201)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE PEG-15 ACETATE (UNII: 11034H9BGQ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISODODECANE (UNII: A8289P68Y2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISODECYL ISONONANOATE (UNII: 4X46Q4U00Z)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
POLYGALA SENEGA ROOT (UNII: M7T6H7D4IF)
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-080-01	1 in 1 CARTON	09/24/2020
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49527-080-02	1 in 1 CARTON	06/06/2022
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49527-080-03	0.2 mL in 1 PACKET; Type 0: Not a Combination Product	11/30/2022	10/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/24/2020

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		202952982	manufacture(49527-080)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(49527-080) , label(49527-080) , manufacture(49527-080)